The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in
BioProcess International
and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment will continue to be safe and efficacious.
This special report series highlights five general subject areas that have been covered in the first 10 years of the CMC Strategy Forum series: quality by design (QbD) and risk management (
Part 1
and
Part 2
; manufacturing strategies; analysis and characterization; assays, biosimilars, and comparability; and process- and product-related impurities...
Both the United States and the European Union offer guidance on a life-cycle approach to process validation. This goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the QbD paradigm to allow for a science- and risk-based selection of critical process parameters, key process indicators, and appropriate specification criteria. The number of runs for process performance qualification (PPQ) must be determined using a risk-based understanding and control of process variability.
This approach allows for more comprehensive use of multiple data sources to strengthen process understanding. Once process performance qualification has been executed, a stage of continued process verification begins for ensuring that a qualified control strategy is sufficient and that the process remains in a state of control. Following an appropriate time frame, process v...
+11The 15th WCBP CMC Strategy Forum, “Raw Material Control Strategies for Bioprocesses,” met on Sunday, 11 January 2009 in San Francisco, CA. This forum considered the design and implementation of control strategies for complex raw materials used in bioprocessing. Discussion focused on key approaches and application of risk assessment tools that can be used to identify and assist in mitigating potential safety and efficacy concerns that can affect the quality of biological products.
Two Sessions
To fully explore the topic, the forum first focused on recognizing and assessing potential risks associated with raw materials (RMs) and then applied those rationales to actual case studies with audience participation. The morning session began with an introduction to the topic followed by five presentations. Areas of discussion included how expectations for raw material control are evolving within changing regulatory and business paradigms including quality by design (QbD), counterfeiting, complex supply chains, and...
+5 Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans.
A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of product types at different life-cycle stages and potentially using different host cells were presented with case studies. Experts from both industry and global health authorities discussed facility design considerations as well as procedural controls such as cleaning validation and product testing. The importance of quality risk management (QRM) to multiproduct operations and controls was also discussed using p...
+7 The importance of investing science and technology into drug product development has become evident as different product types, higher protein concentrations, and doses and requirements for improved delivery of biological drug products have increased. The need to give patients larger and more concentrated doses has challenged formulation scientists and driven development of new technologies that can deliver those doses. Delivery devices fall under device regulations and have distinctly different design, development, and validation requirements from those of protein drug products alone. The regulatory environment also has evolved, whereby a biological drug product (in even simple delivery systems) is now considered a combination product, making additional development consideration and additional requirements applicable.
A CMC Strategy Forum on drug products for biological medicines, including novel delivery devices, challenging formulations and combination products was held in July 2012 in Bethesda, MD. Th...
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